The following data is part of a premarket notification filed by Pivot Medical Inc. with the FDA for Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4mm.
| Device ID | K131769 |
| 510k Number | K131769 |
| Device Name: | CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PIVOT MEDICAL INC. 247 HUMBOLDT CT Sunnyvale, CA 94089 |
| Contact | Jon Cook |
| Correspondent | Jon Cook PIVOT MEDICAL INC. 247 HUMBOLDT CT Sunnyvale, CA 94089 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327294606 | K131769 | 000 |
| 07613252633228 | K131769 | 000 |
| 07613252633099 | K131769 | 000 |
| 07613252633006 | K131769 | 000 |